GSO GS1 Spinal System
Adjustable Cross-Connector
13manufacturers in China registered for this device type
42catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Unified Spine, LLC, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2015-08-06 |
| Record revised | 2024-09-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 501560 | 5.5mm x 60mm Multi-Directional Screw | In distribution |
| 501775 | 7.5mm x 75mm Multi-Directional Screw | In distribution |
| 501765 | 7.5mm x 65mm Multi-Directional Screw | In distribution |
| 501555 | 5.5mm x 55mm Multi-Directional Screw | In distribution |
| 501212 | Small Standard tip Hook for 5.5mm Rod | In distribution |
| 501545 | 5.5mm x 45mm Multi-Directional Screw | In distribution |
| 501218 | Small Narrow Tip Hook for 5.5mm Rod | In distribution |
| 501780 | 7.5mm x 80mm Multi-Directional Screw | In distribution |
| 502100 | 5.5mm x 20″ Rod | In distribution |
| 501217 | Wide Tip Hook for 5.5mm Rod, Large | In distribution |
| 501740 | 7.5mm x 40mm Multi-Directional Screw | In distribution |
| 501735 | 7.5mm x 35mm Multi-Directional Screw | In distribution |
| 501540 | 5.5mm x 40mm Multi-Directional Screw | In distribution |
| 502230 | 30-40mm Adj. Cross-Connector | In distribution |
| 501730 | 7.5mm x 30mm Multi-Directional Screw | In distribution |
| 501219 | Medium Narrow Tip Hook for 5.5mm Rod | In distribution |
| 501214 | Large Standard Tip Hook for 5.5mm Rod | In distribution |
| 501770 | 7.5mm x 70mm Multi-Directional Screw | In distribution |
| 501635 | 6.5mm x 35mm Multi-Directional Screw | In distribution |
| 501760 | 7.5mm x 60mm Multi-Directional Screw | In distribution |
| 501630 | 6.5mm x 30mm Multi-Directional Screw | In distribution |
| 501650 | 6.5mm x 50mm Multi-Directional Screw | In distribution |
| 501215 | Wide Tip Hook for 5.5mm Rod, Small | In distribution |
| 501640 | 6.5mm x 40mm Multi-Directional Screw | In distribution |
| 501525 | 5.5mm x 25mm Multi-Directional Screw | In distribution |
| 502260 | 60-70mm Adj. Cross-Connector | In distribution |
| 501223 | Large Split Tip Hook for 5.5mm Rod | In distribution |
| 501221 | Small Split Tip Hook for 5.5mm Rod | In distribution |
| 501745 | 7.5mm x 45mm Multi-Directional Screw | In distribution |
| 502250 | 50-60mm Adj. Cross-Connector | In distribution |
| 501660 | 6.5mm x 60mm Multi-Directional Screw | In distribution |
| 501216 | Wide Tip Hook for 5.5mm Rod, Medium | In distribution |
| 501625 | 6.5mm x 25mm Multi-Directional Screw | In distribution |
| 501655 | 6.5mm x 55mm Multi-Directional Screw | In distribution |
| 501220 | Large Narrow Tip Hook for 5.5mm Rod | In distribution |
| 501645 | 6.5mm x 45mm Multi-Directional Screw | In distribution |
| 501222 | Medium Split Tip Hook for 5.5mm Rod | In distribution |
| 501755 | 7.5mm x 55mm Multi-Directional Screw | In distribution |
| 502240 | 40-50mm Adj. Cross-Connector | In distribution |
| 501535 | 5.5mm x 35mm Multi-Directional Screw | In distribution |
| 501550 | 5.5mm x 50mm Multi-Directional Screw | In distribution |
| 501750 | 7.5mm x 50mm Multi-Directional Screw | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.